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Results For "CEP"

1785 News Found

Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose


Novel Concepts Medical’s formula disrupts Covid-19 spike protein
Biotech | December 17, 2021

Novel Concepts Medical’s formula disrupts Covid-19 spike protein

The company is now ready to offer clinical testing anywhere in the world after early case studies conducted in Israel have demonstrated recovery within 48 hours


Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark
Medical Device | December 06, 2021

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark

The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, allowing informed decisions on patient and pandemic management decisions


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


Lincoln Pharma plans to launch Cephalosporin product portfolio soon
Drug Approval | September 21, 2021

Lincoln Pharma plans to launch Cephalosporin product portfolio soon

Cephalosporin is a bactericidal, broad-spectrum, and P-lactam antibiotic originally derived from the fungus Acremonium, which is used to treat bacterial infections such as pneumonia, skin infections, ear infection, strep throat, staph infections, tonsillitis, bronchitis among others


Solara announces restoration of CEP for ranitidine hydrochloride
News | July 03, 2021

Solara announces restoration of CEP for ranitidine hydrochloride

Ranitidine Hydrochloride is an important product for Solara and is manufactured at its Cuddalore site


Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
News | June 03, 2021

Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application

Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).


India’s medical devices sector is poised for a pharma-like transformation:  Pranav Sharma, SBU Head - Advanced Surgery, Healthium MedTech
interviews | June 03, 2026

India’s medical devices sector is poised for a pharma-like transformation: Pranav Sharma, SBU Head - Advanced Surgery, Healthium MedTech

The industry is expected to grow significantly over the next few years as healthcare accessibility improves and insurance penetration increases